Regulatory Information
MEDICELL PHARMACEUTICAL (S) PTE. LTD.
MEDICELL PHARMACEUTICAL (S) PTE. LTD.
Therapeutic
Prescription Only
Formulation Information
SYRUP
**4.2 Posology and method of administration** Posology The Oramorph dose is adjusted depending on the severity of pain and with regards to the individual sensitivity of the patient. Under medical control the dose can be increased depending on the severity of pain and depending on the use of analgesics so far. For oral use. The solution should be administered with some liquid (water or juice). The recommended dose depends on the individual pain condition and is for Adults: initial dose usually 10–30 mg morphine sulfate pentahydrate (corresponding to 5–15 ml Oramorph 2 mg/ml - syrup) every 4–6 hours. Immediately prior to administration the prescribed Oramorph dose is measured with the aid of the provided measuring pipette of 5 ml, graduated with marks on every 0.25 ml. _Elderly patients:_ In elderly patients or in patients that should not experience sedation the dosage should be reduced. Older patients (usually 75 years and older) and patients with poor overall physical condition may be sensitive to morphine. Therefore, the adjustment of dose has to be done more carefully and / or the dosage intervals have to be extended. As appropriate, lower dosage strengths have to be given instead. _Patients with impaired liver and/or kidney function:_ In patients with liver and/or kidney dysfunction and if a delayed gastrointestinal passage is suspected Oramorph should be dosed especially carefully. _Discontinuation of therapy:_ An abstinence syndrome may be precipitated if opioid administration is suddenly discontinued. Therefore the dose should be gradually reduced prior to discontinuation.
ORAL
Medical Information
**4.1 Therapeutic indications** Oramorph is indicated for the symptomatic relief of severe chronic pain.
**4.3 Contraindications** - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. - Diarrhoea caused by poisoning. - Acute respiratory insufficiency or respiratory depression, obstructive airways disease. - Concurrent administration with monoamine oxidase (MAO) inhibitors or within 2 weeks of Discontinuation of treatment with MAO (see section 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). The risk-benefit of morphine use should be evaluated when the following medical problems are present: - Acute abdomen. - Asthma attacks and acute and severe bronchial obstruction. - Cardiac arrhythmias. - History of convulsions (see Sect. 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - Acute alcohol intoxication. - Agitation in patients secondary to use of alcohol or hypnotics, emotional instability, suicidal ideation. - Head injury and conditions with increased intracranial pressure. - Acute liver disorders (hepatitis, hepatic porphyria). - Paralytic ileus. - Coma. - Patients with phaeochromocytoma. Morphine and some other opioids can induce the release of endogenous histamine and thereby stimulate catecholamine release. - Pregnancy and lactation (see section 4.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
N02AA01
morphine
Manufacturer Information
MEDICELL PHARMACEUTICAL (S) PTE. LTD.
L.MOLTENI & C.DEI F.LLI ALITTI SOCIETA' DI ESERCIZIO S.P.A.
Active Ingredients
Documents
Package Inserts
Oramorph Syrup 2mg per ml- PI.pdf
Approved: June 16, 2023